The Pediatric Vision Scanner (PVS) is a hand-held research prototype device that uses retinal birefringence scanning technology (co-invented by the PI) to diagnose the presence of amblyopia ("lazy eye") and strabismus (misaligned eyes). These medical eye conditions combine as the leading causes of preventable vision loss in children, and are thus major contributors to worldwide blindness. The overall aim of this project is to determine whether the PVS performance in the laboratory of the inventor can be duplicated in field use by independent investigators. A successful study will confirm that the PVS technology is sufficiently accurate in the field to allow early detection (and thus eradication) of amblyopia and strabismus. Preliminary data indicate that this goal is attainable, but the design of the current prototype must be advanced to allow for definitive clinical testing to establish the PVS as a standard of care and create a path for insurance reimbursement and business success. The current PVS device, which has a 98% accuracy rate detecting amblyopia or strabismus in initial clinical studies, was designed seven years ago for proof of concept. Capitalizing on the experience gained using the current prototype while using advances in electronics and optical technology, it is now possible to significantly improve the design to allow for large scale clinical testing, while also replacing development components that are now unnecessary for clinical testing. Phase I of the project will be geared toward significantly improving the design of the PVS to make it suitable for clinical trials that will independently validate the device and thus create a path to market. A team of engineers will work in unison with a design firm to create a new prototype on the conceptual level. Phase II of the SBIR award will support the assembly and initial debugging of this new design. This phase will also support the distribution of next-generation prototypes to three competitively-selected testing centers for independent assessments on its clinical accuracy, ongoing support of the devices during this phase, and collection of feedback to support design refinement for the final commercial product. PUBLIC HEALTH RELEVANCE: The United States Department of Health and Human Services initiative, Healthy People 2010, places vision screening at a priority, with Objective 28-2 calling for an increase in the proportion of preschool children aged 5 years and under who receive vision screening. This project will directly support that goal by supporting the design and commercialization the Pediatric Vision Screener, a high- technology device that is accurate enough to identify the vast majority of children with amblyopia and strabismus before they reach school age.